Barbed suture in combination with surgical needle

ABSTRACT

A barbed suture for connecting tissue, and a combination surgical needle with a barbed suture. The suture includes an elongated body and a plurality of barbs projecting from the body. Each barb causes the suture to resist movement in an opposite direction from which the barb faces. The disposition of the barbs on the body may be staggered, twist cut multiple spiral, overlapping, or random. Also, the configuration of the barbs may be a certain spirality angle α, barb cut angle Θ, barb cut depth, barb cut length, barb cut distance, corrugated barb underside, arcuate barb base, or varying barb size.

BACKGROUND OF THE INVENTION TECHNICAL FIELD

[0001] This invention relates, in general, to a barbed suture useful forconnecting bodily tissue in various surgical contexts, and moreparticularly, to the optimization of the disposition and/orconfiguration of the barbs on such barbed sutures.

[0002] Various surgical methods employing sutures have been used in thepast for closing or binding together wounds in human or animal tissue,such as skin, muscles, tendons, internal organs, nerves, blood vessels,and the like. More specifically, the surgeon may use a surgical needlewith an attached conventional suture (which can be a smooth monofilamentor can be a multi-filament) to pierce the tissue alternately on opposingfaces of the wound and thus sew the wound closed. Whether the wound isaccidental or surgical, loop stitching is the method often used,especially for surface wounds. The surgical needle is then removed andthe ends of the suture are tied, typically with at least three overhandthrows to form a knot.

[0003] As is well known, conventional sutures can be of non-absorbablematerial such as silk, nylon, polyester, polypropylene, or cotton, orcan be of bio-absorbable material such as glycolic acid polymers andcopolymers or lactic acid polymers and copolymers.

[0004] Since the time of their conception, barbed sutures, which aregenerally of the same materials as conventional sutures, have offerednumerous advantages over closing wounds with conventional sutures. Abarbed suture includes an elongated body that has one or more spacedbarbs, which project from the body surface along the body length. Thebarbs are arranged to allow passage of the barbed suture in onedirection through tissue but resist movement of the barbed suture in theopposite direction. Thus, the main advantage of barbed sutures has beenthe provision of a non-slip attribute. Accordingly, barbed sutures donot have to be knotted, like conventional sutures. Like a conventionalsuture, a barbed suture may be inserted into tissue using a surgicalneedle.

[0005] For instance, U.S. Pat. No. 3,123,077 to Alcamo describes anelongated cord for sewing human flesh, where the cord has a body portionand sharp-edged, resilient barbs projecting from the body at acuteangles relative to the body. The barbed suture can be passed throughtissue in one direction, but resists movement in the opposite direction.

[0006] Sutures with barbs disposed in a bi-directional arrangement, alsocalled double-armed sutures, are shown in U.S. Pat. No. 5,931,855 toBuncke and U.S. Pat. No. 6,241,747 to Ruff. More particularly, thesuture has barbs facing toward one end of the suture for about half thesuture length and barbs facing in the opposite direction toward theother end of the suture for the other half of the suture length. Thisarrangement allows the barbs to move in the same direction as eachrespective suture end is inserted into the first and second sides of awound. Such bi-directional barbed sutures not only are especiallysuitable for closing wounds with edges prone to separation, but alsoobviate the need to secure suture ends together with knotted loops.

[0007] Of interest is European Published Patent Application No.1,075,843 A1 to Sulamanidze and Mikhailov, published Feb. 2, 2001,derived from PCT/RU99/00263 (published as WO 00/51658 on Sep. 8, 2000),priority to RU 991 03732 (Mar. 3, 1999), which shows conical barbsarranged sequentially along the length of a thread and oriented in adirection opposite to that of the thread tension, with the distancebetween barbs being not less than 1.5 times the thread diameter.

[0008] Also of interest is U.S. Pat. No. 5,342,376 to Ruff. This patentshows an insertion device that is useful for positioning a barbed suturein order to close a wound. The insertion device has a tubular body forreceiving a barbed suture, and preferably also has a handle tofacilitate manipulation of the device by the surgeon. The insertiondevice is recommended for use with a barbed suture where the sutureportion being inserted includes barbs facing a direction opposed to thedirection of insertion. Such sutures with barbs opposing the directionof insertion are also shown in “376 to Ruff.

[0009] The disclosures of all patents and patent applications mentionedhere are incorporated by reference.

[0010] Escarpment of barbs into a monofilament, depending on the barbcut depth, reduces the straight pull tensile strength since theeffective suture diameter is decreased. However, the straight pulltensile strength of a barbed suture should be compared to the minimumknot pull strength of a conventional suture (a non-barbed suture) inaccordance with the United States Pharmacopoeia since failure ofconventional sutures (which have to be knotted and must meet a minimumknot pull tensile strength) occurs most frequently at the knot due toincreased local stress.

[0011] To optimize the performance of a barbed suture, it isadvantageous to consider varying the barb geometry (barb cut angle, barbcut depth, barb cut length, barb cut distance, etc.) and/or the spatialarrangement of the barbs. This should not only enhance the tensilestrength of a barbed suture, but also should enhance the ability of abarbed suture in holding and maintaining wound edges together. Unlikeconventional sutures, which place tensions directly at the knots, barbedsutures can spread out the tension along the escarped suture length,often evenly along the length. Optimizing the disposition and/or theconfiguration of the barbs should therefore further increase theeffectiveness of the new barbed suture in maximizing the holdingstrength and minimizing the gap formation along the wound edges. Thelatter is particularly beneficial for promoting wound healing.

[0012] Also, such new barbed sutures should approximate tissue quicklywith appropriate tension, alleviate distortion of tissue, and help tominimize scarring, due to the self-retaining benefits imparted by thebarbs. The new barbed sutures would be especially useful in surgerieswhere minimization of scarring is imperative, such as cosmetic surgery,as well as in surgeries where space is limited, such as endoscopicsurgery or microsurgery.

SUMMARY OF THE INVENTION

[0013] Accordingly, the present invention provides a barbed suture forconnecting human or animal tissue. The barbed suture comprises anelongated body having a first end and a second end. The barbed suturefurther comprises a plurality of barbs projecting from the body. Eachbarb is adapted for enabling the barbed suture to resist movement, whenin tissue, in the direction that is opposite from the direction in whichthat barb faces. The barbed suture further comprises the barbs beingdisposed on the body in a disposition selected from a staggereddisposition, a twist cut multiple spiral disposition, an overlappingdisposition, a random disposition, or combinations thereof.

[0014] For the staggered disposition, the twist cut multiple spiraldisposition, and/or the overlapping disposition, the barbs may all befacing toward only one of the first and second ends. Alternatively, thebarbed suture may have at least a first portion and a second portion,where the barbs of the first portion are facing toward the first end andthe barbs of the second portion are facing toward the second end.

[0015] Also, in an alternative embodiment, the present inventionprovides a barbed suture for connecting human or animal tissue, wherethe suture comprises an elongated body having a first end and a secondend. The suture further comprises a plurality of barbs projecting fromthe body. Each barb is adapted for enabling the suture to resistmovement, when the suture is in tissue, in the direction that isopposite from the direction in which that barb faces. The suture furthercomprises the barbs having a configuration selected from a barb cutangle Θ ranging from about 140 degrees to about 175 degrees, a barb cutdepth with a ratio of cut depth to suture diameter ranging from about0.05 to about 0.6, a barb cut length with a ratio of cut length tosuture diameter ranging from about 0.2 to about 2, a barb cut distancewith a ratio of cut distance to suture diameter ranging from about 0.1to about 6, a corrugated underside, an arcuate base, varying sizes, orcombinations thereof.

[0016] For the twist cut multiple spiral disposition, the barbed suturepreferably has a spirality α angle ranging from about 5 degrees to about25 degrees.

[0017] For the overlapping disposition, it is meant that at least twoadjacent barbs are disposed where one overlaps the other. Duringescarpment of the barbs, the overlapping is created by a barb (i.e., theoverlapping barb) being escarped into the topside of another adjacentbarb (i.e., the overlapped barb), and so on. Hence, part of the topsideof the overlapped barb becomes part of the underside of the overlappingbarb, and so on. Thus, with the overlapping disposition, the barb cutdistance between the overlapping barb and the overlapped barb may beshorter than the barb cut length of overlapped second barb, whereas, ingeneral for barbed sutures, the barb cut distance between two barbs≧thebarb cut length.

[0018] In still another embodiment, the present invention provides abarbed suture for connecting human or animal tissue in combination witha surgical needle, where the combination comprises a barbed sutureattached to a surgical needle. The suture comprises a plurality of barbsprojecting from an elongated body having a first end and a second end.Each barb is adapted for enabling the suture to resist movement, whenthe suture is in tissue, in the direction that is opposite from thedirection in which that barb faces. The ratio of the surgical needlediameter to the suture diameter preferably is about 3:1 or less.Suitably, any of the inventive barbed sutures described here may beattached to a surgical needle.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019]FIG. 1A is a side view of one embodiment of the present invention,showing a barbed suture with barbs disposed in a 180 degree staggeredspacing;

[0020]FIG. 1B is a sectional view along line 1B-1B of the barbed suturein FIG. 1A;

[0021]FIG. 2A is a side view of another embodiment of the presentinvention, showing a barbed suture that is bi-directional with barbsdisposed in a 180 degree staggered spacing;

[0022]FIG. 2B is a sectional view along line 2B-2B of the barbed suturein FIG. 2A;

[0023]FIG. 3A is a side view of another embodiment of the presentinvention, showing a barbed suture with barbs disposed in a 120 degreestaggered spacing;

[0024]FIG. 3B is a sectional view along line 3B-3B of the barbed suturein FIG. 3A;

[0025]FIG. 4A is a side view of another embodiment of the presentinvention, showing a barbed suture that is bi-directional with barbsdisposed in a 120 degree staggered spacing;

[0026]FIG. 4B is a sectional view along line 4B-4B of the barbed suturein FIG. 4A;

[0027]FIG. 5A is a side view of another embodiment of the presentinvention, showing a barbed suture with barbs disposed in a twist cutmultiple spiral disposition;

[0028]FIG. 5B is a sectional view along line 5B-5B of the barbed suturein FIG. 5A;

[0029]FIG. 6A is a side view of another embodiment of the presentinvention, showing a barbed suture that is bi-directional with barbsdisposed in a twist cut multiple spiral disposition;

[0030]FIG. 6B is a sectional view along line 6B-6B of the barbed suturein FIG. 6A;

[0031]FIG. 7A is a sectional side view of a barbed suture, which isbi-directional with barbs disposed in a twist cut multiple spiraldisposition like the barbed suture in FIG. 6A, but illustrated in anenlarged section;

[0032]FIG. 7B is the sectional side view as illustrated in FIG. 7A, butrotated and clamped to align the barbs for measurement of the cutdistance between the barbs;

[0033]FIG. 8 is a side view of another embodiment of the presentinvention, showing a barbed suture with barbs in a random disposition;

[0034]FIG. 9 is a sectional side view of another embodiment of thepresent invention, showing a barbed suture having a barb with acorrugated or serrated underside;

[0035]FIG. 10A is a sectional perspective view another embodiment of thepresent invention, showing a barbed suture having a barb with an arcuatebase;

[0036]FIG. 10B is a sectional top plan view of the barbed suture in FIG.10A;

[0037]FIG. 10C is a cross-sectional view along line 10C-10C of FIG. 10B,

[0038]FIG. 10D is a cross-sectional view along line 10D-10D of FIG. 10B;

[0039]FIG. 11 is a sectional side view of another embodiment of thepresent invention, showing a barbed suture with barbs of various sizes;

[0040]FIG. 12A is a sectional perspective view of another embodiment ofthe present invention, showing a barbed suture with barbs in anoverlapping disposition;

[0041]FIG. 12B is a perspective view of a portion of the overlappingbarbs of the suture of FIG. 12A;

[0042]FIG. 12 C is a plan view of the portion of barbs of FIG. 12B;

[0043]FIG. 12D is a side view along line 12D-12D of FIG. 12C; and

[0044]FIGS. 13A, 13B, 13C, and 13D show various surgical needles, wherea barbed suture is attached to each surgical needle.

DETAILED DESCRIPTION

[0045] As used here, the term wound means a surgical incision, cut,laceration, severed tissue or accidental wound in human or animal skinor other human or animal bodily tissue, or other condition in a human oranimal where suturing, stapling, or the use of another tissue connectingdevice may be required.

[0046] Also as used here, the term tissue includes, but is not limitedto, tissues such as skin, fat, fascia, bone, muscle, organs, nerves, orblood vessels, or fibrous tissues such as tendons or ligaments.

[0047] Moreover, the term polymer as used here generally includes, butis not limited to, homopolymers, copolymers (such as block, graft,random and alternating copolymers), terpolymers, et cetera, and blendsand modifications thereof. Furthermore, the term polymer shall includeall possible structures of the material. These structures include, butare not limited to, isotactic, syndiotactic, and random symmetries.

[0048] Although the sutures are described below in a preferredembodiment with a circular cross section, the sutures could also have anon-circular cross sectional shape that could increase the surface areaand facilitate the formation of the barbs. Other cross sectional shapesmay include, but are not limited to, oval, triangle, square,parallelepiped, trapezoid, rhomboid, pentagon, hexagon, cruciform, andthe like. Typically, barbs are cut into a polymeric filament that hasbeen formed by extrusion using a die with a circular cross section, andthus, the cross section of the filament will be circular, as that iswhat results during such extrusion. However, extrusion dies can becustom made with any desired cross-sectional shape.

[0049] Hence, the term diameter as used here is intended to mean thetransverse length of the cross section, regardless of whether the crosssection is circular or some other shape.

[0050] Suitable diameters for the inventive sutures described below mayrange from about 0.001 mm to about 1 mm, and of course, the diameter maybe from about 0.01 mm to about 0.9 mm, or from about 0.015 mm to about0.8 mm. The typical diameter ranges from about 0.01 mm to about 0.5 mm.The length of the suture can vary depending on several factors such asthe length and/or depth of the wound to be closed, the type of tissue tobe joined, the location of the wound, and the like. Typical suturelengths range from about 1 cm to about 30 cm, more particularly fromabout 2 cm to about 22 cm.

[0051] The terms staggered and staggering as used here in relation tothe disposition of barbs on a suture are intended to mean that thesuture has at least two sets of barbs that are offset with respect toeach other, where the first set is aligned longitudinally on the sutureand the second set is aligned longitudinally on the suture, but a planeperpendicular to the suture and cutting transversely through the sutureand intersecting the base of a barb of the first set will not intersectthe base of a barb of the second set.

[0052] The barbs project from the exterior surface of the suture body onwhich the barbs are disposed. Depending on the intended end use of thebarbed suture, barbs of different sizes may be employed. In general,larger barbs are more suitable for joining certain types of tissue suchas fat tissue or soft tissue. On the other hand, smaller barbs are moresuitable for joining other types of tissue, such as collagen densetissue.

[0053] As noted above, barbed sutures may be made from the samematerials used for making conventional loop sutures. Any particularchosen material for the barbed suture depends on the strength andflexibility requirements.

[0054] More specifically, barbed sutures may be formed from abio-absorbable material that allows the suture to degrade and thus to beabsorbed over time into the tissue as the wound heals. Generally,bio-absorbable materials are polymeric, and depending on the particularpolymer selected, the degradation time in the wound ranges from about 1month to over 24 months. The use of bio-absorbable materials eliminatesthe necessity of removing the sutures from the patient.

[0055] Various bio-absorbable polymers include, but are not limited to,polydioxanone, polylactide, polyglycolide, polycaprolactone, andcopolymers thereof. Commercially available examples are polydioxanone(sold as PDS II, a trade name used by Ethicon for selling surgicalsutures), copolymer of about 67% glycolide and about 33% trimethylenecarbonate (sold as MAXON®, a trademark registered to American Cyanamidfor surgical sutures), and copolymer of about 75% glycolide and about25% caprolactone (sold as MONOCRYL®, a trademark registered to Johnson&Johnson for sutures and suture needles). Barbed sutures made from suchbio-absorbable materials are useful in a wide range of applications.

[0056] Additionally, barbed sutures may be formed from a non-absorbablematerial, which may be a polymer. Such polymers include, but are notlimited to, polypropylene, polyamide (also known as nylon), polyester(such as polyethylene terephthlate, abbreviated here as PET),polytetrafluoroethylene (such as expanded polytetrafluoroethylene,abbreviated here as ePTFE and sold by Gore as GOR-TEX®), polyether-ester(such as polybutester, which is the condensation polymerization ofdimethyl terephthlate, polytetramethylene ether glycol, and1,4-butanediol, and which is marketed by Davis & Geck and by U.S.Surgical, companies owned by Tyco, under the name NOVAFIL®, which is atrademark registered to American Cyanamid for surgical sutures), orpolyurethane. Alternatively, the non-absorbable material may be metal(e.g., steel), metal alloys, natural fiber (e.g., silk, cotton, etcetera), and the like.

[0057] Most of the barbed sutures discussed below are described ashaving their ends being pointed and formed of a material sufficientlystiff to allow for piercing tissue. It is contemplated that the ends ofthe barbed sutures may comprise a surgical needle. In this embodiment,the barbed suture is adapted for attachment, such as by swaging, channelwrapping, heat shrinking, or eyelet threading to the surgical needle forinsertion into tissue.

[0058] Attachment by swaging is well described and is typicallyaccomplished by inserting the suture end into the surgical needle holethat is longitudinally disposed at one end of the surgical needle(usually the hole has been drilled longitudinally into one end of theneedle), followed by crimping the resultant about the needle hole sothat the suture is secured to the surgical needle for insertion intotissue. Also, some surgical needles with a longitudinal hole in one endare heat-shrinkable tubes that are heat shrunk after insertion of thesuture in order to attach the suture to the surgical needle.Additionally, some surgical needles have a channel or trough at one end,and the suture is laid in the trough, followed by wrapping to secure thesuture to the surgical needle. Surgical needles with a conventionaleyelet type of hole transversely disposed in one end of the surgicalneedle could also be used, but are not preferred for barbed sutures. Forthe present invention, part of the discussion below regards surgicalneedles swaged with barbed sutures, but it is contemplated that anyother suitable means of attaching needles can be employed.

[0059] Attachment of sutures and surgical needles is described in U.S.Pat. No. 3,981,307 Borysko, U.S. Pat. No. 5,084,063 to Korthoff, U.S.Pat. No. 5,102,418 to Granger et al., U.S. Pat. No. 5,123,911 to Grangeret al., U.S. Pat. No. 5,500,991 to Demarest et al., U.S. Pat. No.5,722,991 to Colligan, U.S. Pat. No. 6,012,216 to Esteves et al., andU.S. Pat. No. 6,163,948 to Esteves et al. A method for the manufactureof surgical needles is described in U.S. Pat. No. 5,533,982 to Rizk etal. Further, it is noted that the surgical needle may be coated, thecoating allowing for the needle of the inventive combination surgicalneedle/barbed suture to be inserted into tissue with less force than ifthe surgical needle were not coated. The coating may be a polymer, forinstance, a silicone resin coating. For example, an improved siliconizedsurgical needle that requires significantly less force to effect tissuepenetration than a standard siliconized surgical needle is described inU.S. Pat. No. 5,258,01 3 to Granger et al.

[0060] The barbs are disposed in various arrangements on the body of thesuture. The barbs may be formed using any suitable method, includinginjection molding, stamping, cutting, laser, and the like. With regardto cutting, in general, polymeric threads or filaments are purchased,and then the barbs are cut onto the filament body.

[0061] The cutting may be manual, but that is labor intensive and notcost effective.

[0062] A very suitable cutting machine is disclosed in U.S. patentapplication Ser. No. 09/943,733 to Genova et al., assignors to QuillMedical, filed Aug. 31, 2001, the disclosure of which is incorporated byreference. Such a cutting machine has a plurality of blades forescarpment of barbs onto a suture filament. A typical cutting machinefor manufacturing barbed sutures utilizes a cutting bed, a vise, one ormore blade assemblies, and sometimes a template or guide for the blades.The suture filament is placed in the bed and held by the vise, with thetransverse direction of the blades generally disposed in the transversedirection of the suture filament, in order to cut a plurality of axiallyspaced barbs disposed on the exterior of a suture filament.

[0063] With reference now to the drawings, where like reference numeralsdesignate corresponding or similar elements throughout the severalviews, shown in FIG. 1A is a side view of a barbed suture according tothe present invention and generally designated at 1.

[0064] Suture 1 includes elongated body 2 that is generally circular incross section and that terminates in end 4. End 4 is illustrated in oneembodiment as being pointed for penetrating tissue, but it iscontemplated that end 4 may comprise a surgical needle (not shown) forinsertion into tissue. (The other end is not shown.) Also, suture 1includes plurality of closely spaced barbs 7, 9 arranged in a staggeredunidirectional disposition. More specifically, axially spaced barbs 7are radially arranged about 180 degrees from and staggered with respectto axially spaced barbs 9, with barbs 7, 9 facing pointed end 4. Firstset of barbs 7 define a plane that is substantially coplanar with theplane defined by second set of barbs 9, and consequently, barbs 7, 9define substantially the same one plane due to the radial 180 degreearrangement.

[0065]FIG. 1B, which is a cross sectional view along line 1B 1B ofsuture 1 in FIG. 1A, more clearly illustrates angle X, namely the radial180 degree arrangement of barbs 7 with respect to barbs 9. As also canbe seen from FIG. 1B, the stippling illustrates that first barb 7 ofbarbs 7 is closer to pointed end 4 (not shown in FIG. 1B), and thus,seems to be larger than farther away first barb 9 of barbs 9, due to thestaggering. A transverse plane that is perpendicular to suture body 2and that intersects the base of one barb 7 of barbs 7 does not intersectthe base of any barb 9 of barbs 9.

[0066] Suture 1 may be made with a cutting machine that produces twosets of barbs 7, 9, usually one set at a time, in a staggered positionalong suture 1, such as the cutting device described in the above-notedSer. No. 09/943,733 to Genova et al.

[0067] First set of barbs 7 is created by placing and holding a suturefilament in the vise, and then, the set of blades, with a predeterminedlength, splices into the suture filament at an angle selected to createbarbs 7 pointing in one direction toward pointed end 4. Second set ofbarbs 9 is created similarly after offsetting the blades longitudinally(to create the staggering) approximately half of the longitudinaldistance between two of barbs 7 and also rotating the suture filamentabout 180 degrees on the vise, which is equipped to accommodate firstset of barbs 7 that are already cut.

[0068] Shown in FIG. 2A is suture 10, which is another embodiment of thepresent invention and is like suture 1, except that suture 10 isbi-directional. Suture 10 includes elongated body 12 that is generallycircular in cross section. Elongated body 12 terminates in first andsecond pointed ends 14, 16 for penetrating tissue. Also, it iscontemplated that one or both ends 14, 16 may comprise a surgical needle(not shown) for insertion into tissue. Also, suture 10 includesplurality of closely spaced barbs 17, 18, 19, 20 arranged in a staggeredbi-directional disposition.

[0069] More specifically, plurality of axially spaced barbs 17 areradially arranged about 180 degrees from and staggered with respect toplurality of axially spaced barbs 19, with barbs 17, 19 facing pointedend 14 for a portion (about half of the length) of suture 10. Similarly,plurality of axially spaced barbs 18 are radially arranged about 180degrees from and staggered with respect to plurality of axially spacedbarbs 20, with barbs 18, 20 facing pointed end 16 for another portion(approximately the other half of the length) of suture 10. First set ofbarbs 17, 18 define a plane that is substantially coplanar with theplane defined by second set of barbs 19, 20. As a result, all of barbs17, 18, 19, 20 define substantially the same one plane due to the radial180 degree arrangement of first set of barbs 17, 18 with respect tosecond set of barbs 19, 20.

[0070]FIG. 2B is a cross sectional view along line 2B 2B of suture 10 inFIG. 2A, more clearly illustrating angle X, namely the radial 180 degreearrangement. Due to the staggering, first barb 17 of barbs 17 is closerto pointed end 14 (not shown in FIG. 2B), and thus, appears larger thanfarther away first barb 19 of barbs 19, as is illustrated by thestippling. A transverse plane that is perpendicular to suture body 12and that intersects the base of one barb 17 of barbs 17 does notintersect the base of any barb 19 of barbs 19. Likewise, a transverseplane that is perpendicular to suture body 12 and that intersects thebase of one barb 18 of barbs 18 does not intersect the base of any barb20 of barbs 20.

[0071] Suture 10 may be made with the same cutting machine as suture 1,such as the cutting device described in the above-noted Ser. No.09/943,733 to Genova et al., except with the following change in bladedirection.

[0072] For first set of bi-directional barbs 17, 18, after the suturefilament is placed and held in the vise, the blades splice with a firstcutting action into approximately half of the length of the suturefilament to create barbs 17 facing in one direction toward pointed end14. Next, the blades are rotated 180 degrees so that they are nowdisposed in the opposite direction and over the uncut half of thelength. The blades are then allowed to splice into the other half of thelength of the suture filament with a second cutting action to createbarbs 18 facing in the opposite direction toward pointed end 16.

[0073] Next, the blades are offset longitudinally (to create thestaggering) about half of the longitudinal distance between two of barbs17, and also the suture filament is rotated about 180 degrees on thevice, which is equipped to accommodate first set of bi-directional barbs17, 18 that are already cut. Then, for second set of bi-directionalbarbs 19, 20, the blades splice with a first cutting action intoapproximately half the length of the suture filament to create barbs 20facing in one direction toward pointed end 16. The first cutting actionis followed by rotating the blades longitudinally 180 degrees so thatthey are now disposed in the opposite direction and over the uncut halfof the length. The blades are then allowed to splice into the other halfof the length of the suture filament with a second cutting action tocreate barbs 19 facing in the opposite direction toward pointed end 14.

[0074] In an alternative embodiment (not shown) for bi-directionalsuture 10, the portion of suture 10 with barbs 17, 19 may have themfacing toward pointed end 16 and the portion of suture 10 with barbs 18,20 may have them facing toward pointed end 14. With this variation, thebarbed suture would be inserted into tissue with an insertion device,such as that shown in the above-noted U.S. Pat. No. 5,342,376 to Ruff.Additionally, it is noted that, if desired, barbs may be escarped sothat there may be two portions with barbs facing one end and one portionwith barbs facing the other end, or two portions with barbs facing oneend and two portions with barbs facing the other end, and so on (notshown), and thus, if a portion of barbs is not facing the suture end towhich those barbs are adjacent, then, the barbed suture would beinserted into tissue with an insertion device.

[0075] An advantage of a barbed suture having a radial 180 degreearrangement with staggering is that the 180 degree spacing is readilyfabricated on relatively small diameter filaments and the staggeringimproves anchoring performance. Thus, in thin and delicate tissue, wherea smaller suture is desirable, the staggered 180 degree spacinggenerates effective anchoring performance.

[0076] Turning now to FIG. 3A, depicted is a side view of anotherembodiment of a suture according to the present invention, and generallydesignated at suture 30. Suture 30 is like suture 1 shown in FIG. 1A,except that the radial spacing for suture 30 is 120 degrees instead of180 degrees as is shown for suture 1.

[0077] More particularly, suture 30 includes elongated body 32 that isgenerally circular in cross section and that terminates in pointed end34 for penetrating tissue. It is contemplated that end 34 may comprise asurgical needle (not shown) so that the suture can be inserted intotissue. (The other end is not shown.) Additionally, suture 30 includesplurality of closely spaced barbs 35, 37, 39 arranged so that all facein the same direction toward pointed end 34. Hence, the disposition ofbarbs 35, 37, 39 is unidirectional.

[0078] Also, axial spaced barbs 35 are radially arranged about 120degrees from and staggered with respect to axially spaced barbs 37,which are radially arranged about 120 degrees from and staggered withrespect to axially spaced barbs 39. Hence, axially spaced barbs 39 arealso arranged about 120 degrees from and staggered with respect toaxially spaced barbs 35. As a result of the radial 120 degreearrangement, first set of barbs 35 define substantially the same oneplane; second set of barbs 37 define substantially another same oneplane; and third set of barbs 39 define substantially still another sameone plane. Thus, suture 30 has barbs 35, 37, 39 arranged in a staggeredunidirectional 120 degree disposition.

[0079]FIG. 3B is a cross sectional view along line 3B 3B of suture 30 inFIG. 3A and shows with more particularity angle Y, namely the radial 120degree arrangement of barbs 35 with respect to barbs 37, barbs 37 withrespect to barbs 39, and barbs 39 with respect to barbs 35.

[0080] As illustrated by the stippling, first barb 35 of barbs 35,because of the staggering, is closer to pointed end 34 (not shown inFIG. 3B), and thus, seems to be larger than farther away first barb 37of barbs 37. Also, first barb 37 of barbs 37, due to the staggering, iscloser to pointed end 34 (not shown in FIG. 3B), and thus, seems to belarger than even farther away first barb 39 of barbs 39. A transverseplane that is perpendicular to suture body 32 and that intersects thebase of one barb 35 of barbs 35 does not intersect the base of any barb37 of barbs 37. Likewise, a transverse plane that is perpendicular tosuture body 32 and that intersects the base of one barb 37 of barbs 37does not intersect the base of any barb 39 of barbs 39. Similarly, atransverse plane that is perpendicular to suture body 32 and thatintersects the base of one barb 39 of barbs 39 does not intersect thebase of any barb 35 of barbs 35.

[0081] Suture 30 may be made with the same cutting machine as suture 1,such as the cutting device described in the above-noted Ser. No.09/943,733 to Genova et al. The cutting machine is now used to producethree sets of barbs 35, 37, 39, usually one set at a time, in astaggered position along suture 30.

[0082] First set of barbs 35 is created by placing and holding a suturefilament in the vise, followed by the blades, after having been adjustedto a predetermined length, splicing into the suture filament at an anglethat is chosen to create barbs 35 so that all are facing in the samedirection toward pointed end 34.

[0083] Next, the blades are offset longitudinally (to create thestaggering) approximately half of the longitudinal distance between twoof barbs 35. Also, the filament is rotated about 120 degrees on thevise, which is equipped to accommodate first set of barbs 35 that havealready been cut, and then second set of barbs 37 is created in asimilar manner.

[0084] Likewise, the blades are again offset longitudinally (to createthe staggering) approximately half the longitudinal distance between twoof barbs 35, and also the suture filament is rotated about 120 degreeson the vise, which is equipped to accommodate both already cut first setof barbs 35 and already cut second set of barbs 37. Following thelongitudinal movement and rotation, third set of barbs 39 is created ina similar manner.

[0085] Preferably, each successive barb is escarped at a position about120 degrees around suture body 32 from the preceding barb and does notoverlap with any other barb.

[0086] With reference now to FIG. 4A, illustrated is suture 40, anotherembodiment of the present invention. Suture 40 is similar to suture 30,except that suture 40 is bi-directional. Suture 40 includes elongatedbody 42 that is generally circular in cross section and that terminatesin first and second pointed ends 44, 46 for penetrating tissue. Also, itis contemplated that one or both ends 44, 46 may comprise a surgicalneedle (not shown) in order to be inserted into tissue. Suture 40further includes plurality of closely spaced barbs 47, 48, 49, 50, 51,52 arranged in a staggered bi-directional disposition.

[0087] For about half of the length of suture 40, axially spaced barbs47 are circumferentially arranged about 120 degrees from and staggeredwith respect to axially spaced barbs 49, which are radially arrangedabout 120 degrees from and staggered with respect to axially spacedbarbs 51. Consequently, axially spaced barbs 51 are also arranged about120 degrees from and staggered with respect to axially spaced barbs 47.Thus, a portion of suture 40 has all of barbs 47, 49, 51 facing in thesame direction toward pointed end 44.

[0088] For the other half of the length of suture 40, axially spacedbarbs 48 are radially arranged about 120 degrees from and staggered withrespect to axially spaced barbs 50, which are radially arranged about120 degrees from and staggered with respect to axially spaced barbs 52.Consequently, axially spaced barbs 52 are also arranged about 120degrees from and staggered with respect to axially spaced barbs 48.Thus, another portion of suture 40 has all of barbs 48, 50, 52 facing inthe same direction toward pointed end 46.

[0089] As a result of the radial 120 degree arrangement, first set ofbarbs 47, 48 define substantially the same one plane; second set ofbarbs 49, 50 define substantially another same one plane; and third setof barbs 51, 52 define substantially still another same one plane.

[0090]FIG. 4B, which is a cross sectional view along line 4B 4B ofsuture 40 in FIG. 4A, shows more clearly angle Y, namely the radial 120arrangement with greater specificity. As illustrated by the stippling,first barb 47 of barbs 47, on account of the staggering, is closer topointed end 44 (not shown in FIG. 4B), and thus, appears larger thanfarther away first barb 49 of barbs 49. Also because of the staggering,first barb 49 of barbs 49 is closer to pointed end 44 (not shown in FIG.4B), and thus, appears larger than even farther away first barb 51 ofbarbs 51.

[0091] A transverse plane that is perpendicular to suture body 42 andthat intersects the base of one barb 47 of barbs 47 does not intersectthe base of any barb 49 of barbs 49. Likewise, a transverse plane thatis perpendicular to suture body 32 and that intersects the base of onebarb 49 of barbs 49 does not intersect the base of any barb 51 of barbs51. Similarly, a transverse plane that is perpendicular to suture body42 and that intersects the base of one barb 51 of barbs 51 does notintersect the base of any barb 47 of barbs 47. Also, a transverse planethat is perpendicular to suture body 42 and that intersects the base ofone barb 48 of barbs 48 does not intersect the base of any barb 50 ofbarbs 50. Likewise, a transverse plane that is perpendicular to suturebody 32 and that intersects the base of one barb 50 of barbs 50 does notintersect the base of any barb 52 of barbs 52. Similarly, a transverseplane that is perpendicular to suture body 42 and that intersects thebase of one barb 52 of barbs 52 does not intersect the base of any barb48 of barbs 48.

[0092] Suture 40 may be made with the same cutting machine as suture 1,such as the cutting device described in the above-noted Ser. No.09/943,733 to Genova et al., except with the following change in bladedirection.

[0093] For first set of bi-directional barbs 47, 48, after the suturefilament is placed and held in the vise, the blades splice with a firstcutting action into approximately half of the length of the suturefilament to create barbs 47 facing in one direction toward pointed end44. Then, the blades are rotated 180 degrees so that they are nowdisposed in the opposite direction and over the uncut half of thelength. The blades then are allowed to splice into the other half of thelength of the suture filament with a second cutting action to createbarbs 48 facing in the opposite direction toward pointed end 46.

[0094] Next, the blades are offset longitudinally (to create thestaggering) for about half the longitudinal distance between two ofbarbs 47, and also the suture filament is rotated about 120 degrees onthe vise, which is equipped to accommodate first set of bi-directionalbarbs 47, 48 that are already cut. Then, for second set ofbi-directional barbs 49, 50, the blades splice with a first cuttingaction into approximately half of the length of the suture filament tocreate barbs 50 facing in one direction toward pointed end 46. The firstcutting action is followed by rotating the blades 180 degrees so thatthey are now disposed in the opposite direction and over the uncut halfof the suture filament. They then splice into the other half of thelength of the suture filament with a second cutting action to createbarbs 49 facing in the opposite direction toward pointed end 44.

[0095] Then, the blades are again offset longitudinally (to create thestaggering) for about half the longitudinal distance between two ofbarbs 47. Additionally, the suture filament again is rotated about 120degrees on the vise, which is equipped to accommodate already cut firstset of bi-directional barbs 47, 48 and already cut second set ofbi-directional barbs 49, 50. Following the longitudinal movement androtation, the third set of bi-directional barbs 51, 52 are made byhaving the blades splice with a first cutting action into approximatelyhalf of the length of the suture filament to create barbs 51 facing inone direction toward pointed end 44. The first cutting action isfollowed by rotating the blades 180 degrees so that they are nowdisposed in the opposite direction and over the uncut half of the suturefilament. They next splice into the other half of the length of thesuture filament with a second cutting action to create barbs 52 facingin the opposite direction toward pointed end 46.

[0096] Preferably, each successive barb is escarped at a position about120 degrees around suture body 42 from the preceding barb and does notoverlap with any other barb.

[0097] In an alternative embodiment (not shown) for bi-directionalsuture 40, the portion of suture 40 having barbs 47, 49, 51 may havethem facing toward pointed end 46 and the portion of suture 40 havingbarbs 48, 50, 52 may have them facing toward pointed end 44. With thisvariation, the barbed suture would be inserted into tissue with aninsertion device, such as that shown in the above-noted U.S. Pat. No.5,342,376 to Ruff. Additionally, it is noted that, if desired, barbs maybe escarped so that there may be two portions with barbs facing one endand one portion with barbs facing the other end, or two portions withbarbs facing one end and two portions with barbs facing the other end,and so on (not shown), and thus, if a portion of barbs is not facing thesuture end that those barbs are adjacent, then, the barbed suture wouldbe inserted into tissue with an insertion device.

[0098] An advantage of a barbed suture with a radial 120 degreearrangement is that the barbs exert force in three distinct planes thatcompliment each other, resulting in maximization of the retention forceof the suture overall. As noted above, the staggering enhances anchoringperformance.

[0099] Turning now to FIG. 5A, shown is another embodiment of thepresent invention, which is generally designated at suture 60, withradial spacing that is in a twist cut multiple spiral. Suture 60includes elongated body 62 of generally circular cross section.Elongated body 62 terminates in pointed end 64 for penetrating tissue.Also, it is contemplated that end 64 may comprise a surgical needle (notshown) for insertion into tissue. Furthermore, suture 60 includesplurality of closely spaced barbs 67 arranged in a twist cut multiplespiral pattern around body 62 and facing in the same direction towardpointed end 64.

[0100]FIG. 5B is a cross sectional view along line 5B 5B of suture 60 inFIG. 5A. Due to the twist cut multiple spiral disposition, eachrespective barb 67 seems to be smaller and smaller as each is fartherand farther away from pointed end 64 (not shown in FIG. 5B), theillusion of size difference being illustrated by the stippling.

[0101] Suture 60 may be constructed with a similar cutting machine asthat used for making suture 1, such as the cutting device described inthe above-noted Ser. No. 09/943,733 to Genova et al. With a twistcutting method, barbs 67 may be produced in multiple spirals thatpreferably are created at the same time as the suture filament is heldstationary, instead of being rotated, when the cutting takes place.

[0102] More particularly, a suture filament that is about 7 inches(about 178 mm) in length, is longitudinally twisted for a portion of thesuture length, such as 39 times for a portion that is about 4.5 inches(about 114 mm) of the suture length. Thus, an end is secured, and theother end is grasped and rotated 360 degrees, 39 times, so the portionof the suture filament is twisted when the suture is then placed andheld in the vise.

[0103] Twisting preferably is performed 28 to 50 times, and may beperformed more or less, such as 19 to 70 times. Suitably, twisting maybe from about 2 to about 17 twists per inch, or about 3 to about 15twists per inch, or about 5 to about 13 twists per inch (per inch beingper 25.4 mm).

[0104] Next, the blades, after having been adjusted to a predeterminedlength, simultaneously splice into the suture filament. The cuttingaction makes cuts to create barbs 67 so that all are facing in the samedirection toward pointed end 64. After twist cut multiple spiral barbedsuture 60 is released from the vice and untwisted, barbs 67 are disposedin multiple spirals on suture 60.

[0105] Turning now to FIG. 6A, shown is another embodiment of thepresent invention, which is generally designated at suture 70. Suture 70is of a twist cut multiple spiral disposition and thus is similar tosuture 60, except that suture 70 is bi-directional. Suture 70 includeselongated body 72 that is generally circular in cross section and thatterminates in first and second pointed ends 74, 76 for penetratingtissue. It is contemplated that one or both of ends 74, 76 may comprisea surgical needle (not shown) for insertion into tissue.

[0106] Suture 70 further includes plurality of closely spaced barbs 77,78 arranged in two respective spiral patterns, each being a multiplespiral around body 72. Barbs 77, 78 are disposed on middle portion MPthat is approximately 3 inches (approximately 76 mm) of suture 70, witheach end portion EP of suture 70 being barb-free. More particularly,plurality of barbs 77 are arranged in a multiple spiral pattern with allbarbs 77 facing toward pointed end 74 for a part (about half) of middleportion MP along the length of suture 70. Similarly, plurality of barbs78 are arranged in a multiple spiral pattern with all barbs 78 facingtoward pointed end 76 for another part (the other approximate half) ofmiddle potion MP along the length of suture 70.

[0107]FIG. 6B is a cross sectional view along line 6B 6B of suture 60 inFIG. 6A. Due to the multiple spiral configuration, each respective barb77 seems to be smaller and smaller as each is farther and farther awayfrom pointed end 74 (not shown in FIG. 6B), as illustrated by thestippling.

[0108] Suture 70 may be made with the same cutting machine as suture 60,such as the cutting device described in the above-noted Ser. No.09/943,733 to Genova et al., but with the following change in bladedirection. Using the twist cutting method, barbs 77 may be produced inmultiple spirals that preferably are created at the same time, and thenafter the direction change for the blades, barbs 78 may be produced inmultiple spirals that preferably are created at the same time. Thusduring the cutting, the suture filament is held stationary instead ofbeing rotated.

[0109] More specifically, a section of about 4.5 inches (about 114 mm)in length of a suture filament is twisted, such as 39 times for a sutureabout 7 inches (about 178 mm) in length. Thus, an end is secured, andthe other end is grasped and rotated 360 degrees, 39 times, so thetwisted section of the suture filament has about 8⅔ twists per inch (per25.4 mm) when the suture filament is then is placed and held in thevise.

[0110] Twisting preferably is performed 28 to 50 times, and may beperformed more or less, such as 19 to 70 times. Suitably, twisting maybe from about 2 to about 17 twists per inch, or about 3 to about 15twists per inch, or about 5 to about 13 twists per inch (per inch beingper 25.4 mm).

[0111] Next, the blades, after having been adjusted to a predeterminedlength, splice into approximately half of the approximately 3 inch(approximately 76 mm) length of middle portion MP of the approximately4.5 inch (approximately 114 mm) twisted section of the suture filamentin a first cutting action with the blades making cuts to create barbs 77so that all are facing in one direction toward pointed end 74. Dependingon how many blades there are on the cutting machine and how many barbs77 are desired, there may be one cutting motion to cut all barbs 77simultaneously, or there may be repeated cutting motions until thedesired number of barbs 77 are escarped into a portion of the suturefilament.

[0112] Then, the blades are rotated 180 degrees so that they are nowdisposed in the opposite direction and over the other half of theapproximately 3 inch (approximately 76 mm) length of middle portion MPof the approximately 4.5 inch (approximately 114 mm) twisted section ofthe suture filament. The blades are then allowed to splice into theother half in a second cutting action with the blades making cuts tocreate barbs 78 so that all are facing in the opposite direction towardpointed end 76. Depending on how many blades there are on the cuttingmachine and how many barbs 78 are desired, there may be one cuttingmotion to cut all barbs 78 simultaneously, or there may be repeatedcutting motions until the desired number of barbs 78 are escarped into aportion of the suture filament.

[0113] When twist cut multiple spiral barbed suture 70 is released fromthe vise and untwisted, the first cuts and the second cuts result inbarbs 77, 78 being in two respective multiple spiral patterns on tworespective portions of suture 70, the two respective portions definingmiddle portion MP of about 3 inches (about 76 mm) in length.

[0114] More particularly, several twist cut multiple spiral, barbedsutures were manufactured from a monofilament having a diameter of about0.018 inch (about 0.457 mm) and spun from polydioxanone (which is asynthetic absorbable suture material). A diameter of about 0.018 inch(about 0.457 mm) is slightly larger than the size 0 synthetic absorbablesuture, which has a diameter range from about 0.35 mm to about 0.399 mmin accordance with the specifications of the United States Pharmacopoeia(USP).

[0115] Each suture contained a total of 78 barbs introduced in tworespective multiple spiral patterns around the circumference of thesuture. Since the barbed suture was bi-directional, the barbs weredivided into a left group with 39 barbs disposed on a first portion ofthe suture and a right group with 39 barbs on a second portion of thesuture, each group opposing the direction of the other group from theapproximate middle of the suture. The specific cutting machine employedhad 13 blades. Thus, for each group of 39 barbs, there were 3 cuttingmotions (3×13=39), with the blades being offset with a guide for each ofthe 3 cutting motions.

[0116] Each suture was about 7 inches (about 178 mm) long. The middleportion MP was about 3 inches (about 76 mm) long and contained the 78barbs that were escarped into the suture filament. Extending beyond the3 inch (76 mm) barbed middle portion MP were two unbarbed end portionsEP of the suture that were each about 2 inches (about 51 mm) long.Depending on the suturing technique, one or both ends of the barbedsuture may be sufficiently pointed and rigid for insertion into tissue,or may comprise a straight or curved surgical needle.

[0117] The strength of the twist cut, 7 inch (178 mm) barbed sutures wastested by two methods. One method was a straight pull tensile strengthtest with a Universal Tester and the other method was an in vivoperformance test with dogs.

[0118] For the straight pull tensile strength measurement, testing wasperformed using a Test Resources Universal Tester, Model 200Q. Theaverage reading of 10 repeated measurements made for each kind of suturewas recorded for the barbed sutures and for the comparison unbarbedsutures.

[0119] Comparison unbarbed sutures were polydioxanone monofilaments (asynthetic absorbable suture material) of various suture diameters ofabout 0.018 inch (about 0.457 mm), about 0.015 inch (about 0.381 mm),and about 0.0115 inch (about 0.292 mm), which are respectively slightlylarger than the United States Pharmacopoeia sizes 0, 2-0, and 3-0 forsynthetic absorbable sutures. In accordance with United StatesPharmacopoeia specifications for synthetic absorbable sutures, size 0has a diameter range of about 0.35 mm to about 0.399 mm; size 2-0 has adiameter range of about 0.30 mm to about 0.339 mm; and size 3-0 has adiameter range of about 0.20 mm to about 0.249 mm.

[0120] Each barbed suture was gripped at each end by being held withcork gasket padding in two respective serrated jaws, whereas eachunbarbed suture was gripped at each end by being wrapped around tworespective capstan roller grips. Capstan rollers were used for holdingthe unbarbed sutures to avoid stress and distension.

[0121] The portion of each suture specimen between the two grippedplaces was about 5 inches (about 126 mm) in length, which, in the caseof barbed sutures, contained the entire 3 inches (76 mm) of the barbedmiddle portion.

[0122] Each specimen was pulled longitudinally at a rate of about 10inches (about 254 mm) per minute until breakage occurred. The peak loadwas recorded as the straight pull tensile strength.

[0123] The results are summarized in Table 6A below, and the far rightcolumn denotes the USP knot pull test minimum requirements forconventional (unbarbed) sutures made from a synthetic absorbablematerial. TABLE 6A (Tensile Strength) Barbed or Suture Straight Pull USPMinimum Requirements Unbarbed Size (pounds) for Knot Pull (pounds)Unbarbed 0 17.72 8.60 Unbarbed 2-0 11.86 5.91 Unbarbed 3-0 8.82 3.90Barbed 0 7.03 not applicable

[0124] As can be seen, escarpment of barbs into the size 0 polydioxanonemonofilament reduced the straight pull tensile strength by approximately60% as compared to the conventional unbarbed size 0 polydioxanonemonofilament (7.03 pounds=40% of 17.72 pounds).

[0125] However, the straight pull tensile strength of 7.03 pounds atbreakage for the size 0 polydioxanone barbed suture (which, due to theescarpment of the barbs, has an effective diameter that is smaller thanthe diameter of the conventional unbarbed size 0 polydioxanone suture)compared favorably with the minimum USP knot pull requirement of 8.60pounds for the size 0 polydioxanone conventional unbarbed suture.

[0126] Additional straight pull tensile strength tests were performed onadditional size 0 polydioxanone barbed sutures, as discussed below inTables 7K-7Z, in connection with FIGS. 7A and 7B.

[0127] For the in vivo performance, 3 mongrel dogs, each about 14 kg,were used. On each dog, 7 incisions were made at the thorax (twice),thigh (twice), flank, ventral midline, and paramedian, each of the 7incisions having 1, 2, or 3 closure sites. The length of each incisionranged from about 0.5 inch (about 12.5 mm) to about 4 inches (about 101mm) and the depth of each incision was from the superficial dermis tothe peritoneum.

[0128] Using the barbed sutures (all made from size 0 polydioxanonemonofilament), 24 of the sites were closed. For comparison, theremaining sites were closed with various diameter sizes of conventionalunbarbed sutures (1 site with size 2-0 silk braided filament, 6 siteswith size 2-0 nylon monofilament, and 7 sites with size 3-0polydioxanone monofilament), which were knotted. All closing of siteswas performed according to a randomized scheme.

[0129] The dogs were monitored daily, and then subjected to euthanasiaat 14 days. At the time of death, the incisions were evaluatedmacroscopically. With regard to various tissues, incision sizes, andlocations on the dogs, all sites apposed with the size 0 polydioxanonebarbed sutures stayed closed and appeared to be healing normallythroughout the 14 day observation period. No dehiscence occurred.

[0130] The site apposed with the conventional unbarbed silk sutures andthe sites apposed with the conventional unbarbed polydioxanone suturesalso healed will without complications. No dehiscence occurred.

[0131] For the 6 topical skin sites closed with the size 2-0 nylonmonofilament conventional unbarbed sutures, 3 sites exhibited partial orcomplete suture loss, apparently due to self-mutilation by the dogs.Knots in the conventional sutures possibly caused discomfort by creatinglocalized pressure, and animals cannot understand that they should notmanipulate the sutures. Thus, barbed sutures should help obviate theproblem of an animal manipulating and pulling out the sutures.

[0132] In summary, the in vivo performance of the size 0 polydioxanonebarbed sutures was efficacious when compared to the size 2-0 silkbraided filament unbarbed sutures, the size 2-0 nylon monofilamentunbarbed sutures, and the size 3-0 polydioxanone monofilament unbarbedsutures.

[0133] In an alternative embodiment (not shown) for bi-directional twistcut, multiple spiral suture 70, the portion of suture 70 on which isdisposed barbs 77 may have barbs 77 facing toward pointed end 76 and theportion of suture 70 on which is disposed barbs 78 may have barbs 78facing toward pointed end 74. With this variation, the barbed suturewould be inserted into tissue with an insertion device, such as thatshown in the above-noted U.S. Pat. No. 5,342,376 to Ruff. Also ifdesired, it is noted that barbs may be escarped so that there may be 2portions with barbs facing an end and 1 portion with barbs facing theother end, or 2 portions with barbs facing an end and 2 portions withbarbs facing the other end, and so on (not shown), and thus, if aportion of barbs is not facing the suture end to which those barbs areadjacent, then, the barbed suture would be inserted into tissue with aninsertion device.

[0134] An advantage of a barbed suture having a twist cut, multiplespiral disposition is that such a barbed suture affords better woundholding capability as compared to the 120 degree spaced barbed suture.The reason is that the twist cut, multiple spiral pattern results ingroups of barbs that complement successive and preceding groups ofbarbs, which tends to provide improved anchoring when the suture is intissue. This feature is especially useful for tissue such as fat tissue,which has fewer connective fibers compared with other types of tissues,so that greater suture retention force is desirable.

[0135] With reference now to FIG. 7A, shown is a sectional side view ofbarbed suture 80. Barbed suture 80 has plurality of closely spaced barbs81 on elongated suture body 82 of generally circular cross section. Eachbarb 81 has barb tip 85. Shown are suture longitudinal axis A, suturediameter SD, barb length L, barb cut depth D, barb cut angle Θ, cutdistance P, spirality angle α, cut-out depression CD, and tip T ofcut-out depression CD.

[0136]FIG. 7B is the sectional side view as illustrated in FIG. 7A, butrotated and clamped to align the barbs for measurement of the cutdistance P between barbs 81.

[0137] Barbed suture 80 is a twist cut, multiple spiral, bi-directionalbarbed suture, like suture 70 in FIG. 6A, but illustrated as an enlargedsection in order to show more detail with respect to the configurationof barbs 81 vis-a-vis suture longitudinal axis A, suture diameter SD,barb length L, barb cut depth D, barb cut angle Θ, cut distance P,spirality angle α, cut-out depression CD, and terminus T of cut-outdepression CD.

[0138] More specifically, several twist cut, multiple spiral, barbedsutures were manufactured from monofilament spun from polydioxanone andhaving a diameter of about 0.018 inch (about 0.457 mm, which is slightlymore than the USP requirement for a size 0 synthetic absorbable suture).Each suture contained 78 barbs introduced in 2 separate multiple spiralpatterns around the circumference of the suture. Since the barbs werebi-directional, they were divided into a left group with 39 barbs and aright group with 39 barbs, each group opposing the direction of theother group from the approximate middle of the suture. Each suture wasabout 7 inches (about 178 mm) long. The middle portion was about 3inches (about 76 mm) of the suture and contained the 78 barbs that wereescarped into the suture filament. Extending beyond the 3 inch (76 mm)barbed middle portion toward each suture end were two unbarbed endportions of the suture filament that were each about 2 inches (about 51mm) long. Depending on the stitching technique, one or both ends of thebarbed suture may be sufficiently pointed and rigid for insertion intotissue, or may comprise a straight or curved needle.

[0139] In order to characterize the configuration of barbs 81, an OptemZoom 100 custom microscope with both ring and back lighting was usedtogether with a CCD brand video camera in order to measure selectedbarbs 81 at ×21.5 magnification from each of the left and right groups.

[0140] The average was calculated for 10 repeated measurements (5 fromthe left group of barbs and 5 from the right group of barbs on the samesuture) that were made for each of cut angle Θ and cut depth D. Barb cutangle Θ was measured from the surface of the cut to the outer surface ofbarbed suture 80. Barb cut depth D was measured along a perpendicularfrom the outer surface of barbed suture 80 toward longitudinal axis A ofbarbed suture 80. The measurements enabled cut length L to be calculatedusing the following formula.

L=D/{ Sin (180−Θ)}

[0141] Also, angle α of spirality was measured microscopically onvarious barbed sutures 80 as follows. When the twisted suture filamentis gripped by the vise during cutting of barbs 81, the vise leaves avery light mark designated as line M impressed on the suture filament.Thus, line M will be parallel to the longitudinal axis of the vise whilethe twisted suture filament is being held in the vise. If the vise doesnot leave a light mark on the suture filament, then line M can bedetermined in that it is parallel to a line connecting the tworespective terminus T of the two successive cut-out depressions CD leftin suture body 82 from the escarpment of two successive barbs 81. Aftercutting of barbs 81, when barbed suture 80 is released from the vise anduntwisted so that suture 80 lies free, then line M spirals on suturebody 82 around barbed suture 80, forming angle α of spirality.

[0142] Specifically for measuring spirality angle α, the Optem Zoom 100custom microscope was set with ring lighting at 60 and back lighting atcoarse 12 and fine 10. Also, imaging analysis system software was used.Spirality angle α was then measured between the outer surface of thebarbed suture and line M. The average was calculated for 10 repeatedmeasurements (5 from the left group of barbs and 5 from the right groupof barbs on the same suture).

[0143] Then, barbed suture 80 was mounted in a twisting device with oneend of suture 80 clamped in a fixed position. The other end of suture 80was rotated to insert twist until barbs 81 were aligned. Next on barbedsuture 80, longitudinal cut distance P between two adjacent barbs 81 wasmeasured microscopically between the two respective terminus T of thetwo successive cut-out depressions CD left in suture body 82 from theescarpment of two successive barbs 81. The average was calculated for 10repeated measurements (5 from the left group of barbs and 5 from theright group of barbs on the same suture).

[0144] The results are summarized in the following Tables 7A, 7B, 7C,and 7D. TABLE 7A (size 0 barbed suture) Ratio of D, L, or P over SutureDiameter Measurement Units Left Right (0.457 mm) cut angle ⊖ degrees 156 +/−  157 +/− not applicable 2 1 cut depth D mm 0.15 +/− 0.16 +/−0.35 0.02 0.04 cut length L mm 0.36 +/− 0.40 +/− 0.87 0.03 0.10 cutdistance mm 0.90 +/− 0.88 +/− 1.92 P 0.17 0.15

[0145] TABLE 7B (size 0 barbed suture) Ratio of D, L, or P Standard overSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angle⊖ degrees 151 1.642 not applicable cut depth D mm 0.215 0.027 0.47 cutlength L mm 0.446 0.042 0.97 cut distance P mm 0.962 0.073 2.1 spiralityangle degrees 20.833 1.602 not applicable α

[0146] TABLE 7C (size 0 barbed suture) Ratio of D, L, or P Standard overSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angle⊖ degrees 154 2.870 not applicable cut depth D mm 0.205 0.033 0.45 cutlength L mm 0.469 0.044 1.03 cut distance P mm 0.975 0.103 2.13spirality angle degrees 19.333 1.506 not applicable α

[0147] TABLE 7D (size 0 barbed suture) Ratio of D, L, or P Standard overSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angle⊖ degrees 155 2.390 not applicable cut depth D mm 0.186 0.026 0.41 cutlength L mm 0.437 0.039 0.96 cut distance P mm 0.966 0.071 2.11spirality angle degrees 18.833 2.137 not applicable α

[0148] Also, some additional measurements of angle α were performed on afew additional bi-directional twist cut, multiple spiral barbed sutureswith a diameter of about 0.018 inch (about 0.457 mm, slightly more thanthe USP requirement for a size 0 synthetic absorbable suture). The meanaverage was 16.87 and the standard deviation was+0.85.

[0149] Additionally, measurements of barb cut angle Θ, barb length L,barb cut depth D, and cut distance P were performed on 3 additionalbi-directional twist cut, multiple spiral barbed sutures like sutures80, but having a diameter of about 0.0115 inch (about 0.292 mm, which isslightly more than the USP requirement for a size 3-0 syntheticabsorbable suture), and measurements of spirality angle α were performedon 2 of these 3 additional barbed sutures. Also, measurements of barbcut angle Θ, barb length L, barb cut depth D, cut distance P, andspirality angle α were performed on 3 additional bi-directional twistcut, multiple spiral barbed sutures like sutures 80, but with a diameterof about 0.015 inch (about 0.381 mm, which is slightly more than the USPrequirement for a size 2-0 synthetic absorbable suture). The results aresummarized in the following Tables 7E, 7F, 7G, 7H, 7I, and 7J. TABLE 7E(size 3-0 barbed suture) Ratio of D, L, or P Standard over SutureDiameter Measurement Units Average Deviation (0.292 mm) cut angle ⊖degrees 166 1.651 not applicable cut depth D mm 0.107 0.007 0.37 cutlength L mm 0.443 0.042 1.52 cut distance P mm 0.956 0.079 3.27spirality angle degrees not not not applicable α tested applicable

[0150] TABLE 7F (size 3-0 barbed suture) Ratio of D, L, or P Standardover Suture Diameter Measurement Units Average Deviation (0.292 mm) cutangle ⊖ degrees 164 2.055 not applicable cut depth D mm 0.106 0.006 0.36cut length L mm 0.395 0.042 1.35 cut distance P mm 0.959 0.074 3.28spirality angle degrees 7.329 0.547 not applicable α

[0151] TABLE 7G (size 3-0 barbed suture) Ratio of D, L, or P Standardover Suture Diameter Measurement Units Average Deviation (0.292 mm) cutangle ⊖ degrees 165 1.031 not applicable cut depth D mm 0.104 0.009 0.36cut length L mm 0.390 0.035 1.34 cut distance P mm 0.975 0.103 3.34spirality angle degrees 7.258 0.636 not applicable α

[0152] TABLE 7H (size 2-0 barbed suture) Ratio of D, L, or P Standardover Suture Diameter Measurement Units Average Deviation (0.381 mm) cutangle ⊖ degrees 160.2 1.320 not applicable cut depth D mm 0.152 0.0190.40 cut length L mm 0.449 0.057 1.18 cut distance P mm 0.944 0.098 2.48spirality angle degrees 9.40 1.606 not applicable α

[0153] TABLE 7I (size 2-0 barbed suture) Ratio of D, L, or P Standardover Suture Diameter Measurement Units Average Deviation (0.381 mm) cutangle ⊖ degrees 161.0 1.707 not applicable cut depth D mm 0.158 0.0140.41 cut length L mm 0.489 0.054 1.28 cut distance P mm 0.962 0.054 2.52spirality angle degrees 7.96 1.075 not applicable α

[0154] TABLE 7J (size 2-0 barbed suture) Ratio of D, L, or P Standardover Suture Diameter Measurement Units Average Deviation (0.381 mm) cutangle ⊖ degrees 161.0 1.506 not applicable cut depth D mm 0.154 0.0170.40 cut length L mm 0.474 0.058 1.24 cut distance P mm 0.973 0.068 2.55spirality angle degrees 6.53 1.755 not applicable α

[0155] Additional measurements were performed on several other twistcut, multiple spiral, barbed sutures manufactured from monofilament spunfrom polydioxanone and having a diameter of about 0.018 inch (about0.457 mm, which is slightly more than the USP requirement for a size 0synthetic absorbable suture) and thus similar to the above-describedtested barbed sutures, except that these other barbed sutures were cutwith a different cutting machine, namely a machine with one blade thatmoved longitudinally along the twisted filament between cutting strokesand that was controlled with a computer to make the various cuts for theescarpment of the barbs. These other barbed sutures were also tested forstraight pull tensile strength and for chamois cloth closure strength.(A discussion of how chamois cloth closure strength is performed can beseen below in connection with FIGS. 13A and 13B.) The results for theseother barbed sutures are summarized in the following Tables 7K 7Z. TABLE7K (size 0 barbed suture) Ratio of D, L, P Standard over Suture DiameterMeasurement Units Average Deviation (0.457 mm) cut angle ⊖ degrees 152.60.718 not applicable cut depth D mm 0.221 0.011 0.48 cut length L mm0.479 0.022 1.05 cut distance P mm 0.784 0.015 1.71 spirality angledegrees 12.9 0.453 not applicable α

[0156] TABLE 7L (size 0 barbed suture) Ratio of D, L, P Standard overSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angle⊖ degrees 152.4 0.947 not applicable cut depth D mm 0.216 0.014 0.47 cutlength L mm 0.465 0.024 1.02 cut distance P mm 0.774 0.015 1.69spirality angle degrees 13.2 0.349 not applicable α

[0157] TABLE 7M (size 0 barbed suture) Ratio of D, L, P Standard overSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angle⊖ degrees 152.3 0.576 not applicable cut depth D mm 0.227 0.015 0.50 cutlength L mm 0.489 0.034 1.07 cut distance P mm 0.796 0.018 1.74spirality angle degrees 13.1 0.193 not applicable α

[0158] TABLE 7N (size 0 barbed suture) Ratio of D, L, P Standard overSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angle⊖ degrees 152.8 0.612 not applicable cut depth D mm 0.207 0.007 0.45 cutlength L mm 0.453 0.016 0.99 cut distance P mm 0.798 0.017 1.75spirality angle degrees 13.6 0.560 not applicable α

[0159] TABLE 7O (size 0 barbed suture) Ratio of D, L, P over StandardSutur Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 152.9 0.549 not applicable cut depth D mm 0.188 0.016 0.41 cutlength L mm 0.413 0.030 0.90 cut distance P mm 0.787 0.024 1.72spirality angle α degrees 13.8 0.270 not applicable

[0160] TABLE 7P (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 153.1 0.655 not applicable cut depth D mm 0.204 0.007 0.45 cutlength L mm 0.451 0.019 0.99 cut distance P mm 0.792 0.018 1.73spirality angle α degrees 13.6 0.410 not applicable

[0161] TABLE 7Q (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 163.1 0.505 not applicable cut depth D mm 0.245 0.013 0.54 cutlength L mm 0.842 0.045 1.84 cut distance P mm 0.774 0.009 1.69spirality angle α degree 10.8 0.449 not applicable

[0162] TABLE 7R (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 161.1 1.126 not applicable cut depth D mm 0.233 0.017 0.51 cutlength L mm 0.721 0.035 1.58 cut distance P mm 0.773 0.010 1.69spirality angle α degrees 12.6 0.189 not applicable

[0163] TABLE 7S (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 160.9 0.708 not applicable cut depth D mm 0.240 0.014 0.52 cutlength L mm 0.734 0.037 1.61 cut distance P mm 0.774 0.009 1.69spirality angle α degrees 13.6 0.312 not applicable

[0164] TABLE 7T (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 154.6 1.434 not applicable cut depth D mm 0.210 0.009 0.46 cutlength L mm 0.492 0.026 1.08 cut distance P mm 0.538 0.011 1.18spirality angle α degrees 12.3 0.223 not applicable

[0165] TABLE 7U (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 152.9 0.809 not applicable cut depth D mm 0.212 0.014 0.46 cutlength L mm 0.464 0.026 1.01 cut distance P mm 0.530 0.015 1.16spirality angle α degrees 13.7 0.411 not applicable

[0166] TABLE 7V (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 153.4 0.903 not applicable cut depth D mm 0.221 0.010 0.48 cutlength L mm 0.495 0.023 1.08 cut distance P mm 0.537 0.012 1.17spirality angle α degrees 13.9 0.605 not applicable

[0167] TABLE 7W (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 155.2 0.829 not applicable cut depth D mm 0.202 0.008 0.44 cutlength L mm 0.483 0.017 1.06 cut distance P mm 0.789 0.031 1.73spirality angle α degrees 12.6 0.328 not applicable

[0168] TABLE 7X (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 155.5 0.799 not applicable cut depth D mm 0.200 0.010 0.44 cutlength L mm 0.484 0.027 1.06 cut distance P mm 0.798 0.017 1.75spirality angle α degrees 11.8 0.362 not applicable

[0169] TABLE 7Y (size 0 barbed suture) Ratio of D, L, P over StandardSuture Diameter Measurement Units Average Deviation (0.457 mm) cut angleΘ degrees 155.4 0.560 not applicable cut depth D mm 0.196 0.008 0.43 cutlength L mm 0.471 0.017 1.03 cut distance P mm 0.799 0.019 1.75spirality angle α degrees 11.8 0.496 not applicable

[0170] TABLE 7Z Straight Pull Chamois Cloth Closure Barbed SutureStrength (pounds) Strength (pounds to rupture) Sample 1 (Tables 7.2911.23 7K-7M) Sample 2 (Tables 8.73 12.14 7N-7P) Sample 3 (Tables 8.59.22 7Q-7S) Sample 4 (Tables 5.92 9.27 7T-7V) Sample 5 (Tables 7.69 9.977W-7Y)

[0171] Although all the above-noted measurements were performed onbi-directional, twist cut, multiple spiral barbed sutures, thebelow-noted desirable ranges for measurements for barb length L, barbcut depth D, barb cut angle Θ, and/or cut distance P should be the samefor the various other inventive barbed sutures described here.

[0172] A suitable ratio of cut length L to barbed suture diameter SDranges from about 0.2 to about 2, more preferably from about 0.4 toabout 1.7, even more preferably from about 0.8 to about 1.5. However,very suitable barbed sutures may have a ratio of cut length L to barbedsuture diameter SD from about 1 down to about 0.2, whereby the ratio ofthe highest possible barb elevation (the elevation of barb tip 85 abovesuture body 82) to the suture diameter SD correspondingly ranges fromabout 1 down to about 0.2. (The highest possible barb elevation is thesame as the barb length L.) Also, a suitable ratio of cut depth D tobarbed suture diameter SD ranges from about 0.05 to about 0.6, morepreferably from about 0.1 to about 0.55, even more preferably from about0.2 to about 0.5.

[0173] Regardless, length L may be desirably varied depending on theintended end use, since larger barbs are more suitable for joiningcertain types of tissue such as fat tissue or soft tissue, whereassmaller barbs are more suitable for joining other types of tissues suchas fibrous tissue. As discussed in more detail below vis-a-vis FIG. 11,there will also be instances where a barb configuration that is acombination of large, medium, and/or small barbs disposed on the samesuture will be desirable, for instance, when the barbed suture isemployed in tissue that has differing layer structures.

[0174] Cut angle Θ formed between the barb and the elongated suture bodydesirably would range from about 140 degrees to about 175 degrees, morepreferably would range from about 145 degrees to about 173 degrees. Themost preferred cut angle Θ for all barbs ranges from about 150° to about170°.

[0175] For instance, for a polydioxanone barbed suture with a diameterof about 0.018 inch (about 0.457 mm), which is slightly larger that theUSP requirement for a synthetic absorbable suture of size 0, thepreferred barb length L would be 0.45 mm; the preferred barb depth Dwould be 0.2 mm; and the preferred barb cut angle would be 153 degrees.

[0176] Longitudinal spacing between any two barbs is generally effectedwith the goal of creating as many barbs as possible along the suture,and is a factor in the ability of the barbed suture to anchor tissueswhile maintaining firmness. As barbs are spaced farther apart,tissue-anchoring capacity decreases. Nevertheless, if barbs are spacedtoo close, the integrity of the filament may be jeopardized, which couldlead to a tendency of the barbs to peel back and also to a decrease insuture tensile strength.

[0177] Generally, a suitable ratio of cut distance P to barbed suturediameter SD ranges from about 0.1 to about 6, more preferably from about0.5 to about 4.5, even more preferably from about 1.0 to about 3.5. Verysuitable barbed sutures may have a ratio of cut distance P to barbedsuture diameter SD from about 1.5 down to about 0.2, whereby cutdistance P may be as low as about 0.1, particularly for the overlappingbarb embodiment, which is discussed in more detail below vis-á-vis FIGS.12A, 12B, 12C, and 12D.

[0178] Additionally, spirality angle α formed between line M and thelongitudinal direction of the elongated suture body for a twist cut,multiple spiral barbed suture typically would range from about 5 degreesto about 25 degrees, more preferably from about 7 degrees to about 21degrees. The most preferred angle α for all barbs on a twist cut,multiple spiral barbed suture is about 10° to about 18°.

[0179] Turning now to FIG. 8, shown is suture 90, which is anotherembodiment of the present invention. Suture 90 includes elongated body92 that is generally circular in cross section. Elongated body 92terminates in first and second pointed ends 94, 96 for penetratingtissue. It is contemplated that one or both ends 94, 96 may comprise asurgical needle (not shown) for insertion into tissue. Additionally,suture 90 includes plurality of closely spaced barbs 97 arranged in arandom disposition.

[0180] Suture 90 may be made with the same cutting machine as theabove-discussed sutures, such as the cutting device described in theabove-noted Ser. No. 09/943,733 to Genova et al. With combinations ofthe above-described methods for making the 180 degree disposition(sutures 1, 10), the 120 degree disposition (sutures 30, 40), and/or thetwist cut multiple spiral disposition (sutures 60, 70, 80), barbedsuture 90 with a very random barb disposition is obtained. The advantageof the random disposition is that the many barb angles provide superioranchoring in tissues and thus afford superior wound holding properties.With the random disposition, the barbed suture would be inserted intotissue with an insertion device, such as that shown in the above-notedU.S. Pat. No. 5,342,376 to Ruff.

[0181] With regard to FIG. 9, shown is a sectional side view of barbedsuture 100, which is another embodiment of the present invention. Suture100 includes elongated suture body 102 of generally circular crosssection. Also, suture body 102 has disposed on it a plurality of closelyspaced barbs 107. Each barb 107 has a barb configuration such that barbunderside 108 is serrated or corrugated. One or both suture ends (notshown) are pointed for penetrating tissue and it is contemplated thatone or both may comprise a surgical needle (not shown) for insertioninto tissue.

[0182] Suture 100 may be made with the same cutting machine as theabove-discussed sutures, such as the cutting device described in theabove-noted Ser. No. 09/943,733 to Genova et al. Barb 107 havingserrated underside 108 is achieved by vibrating or oscillating thecutting blades of the cutting device when barbs are being escarped intothe body of a monofilament. It is intended that any of the barbedsutures of the present invention as described here may have barbs with aconfiguration that includes a serrated or corrugated underside.

[0183] With reference now to FIGS. 10A and 10B, depicted in FIG. 10A isa perspective view and depicted in FIG. 10B is a top view of barbedsuture 110, which is another embodiment of the present invention. Suture110 includes elongated suture body 112 of generally circular crosssection. Also, suture body 112 has disposed on it a plurality of closelyspaced barbs 115 having barb tips 117 (one barb 115 is shown forpurposes of brevity). Barb 115 has a configuration with an arcuate base119 where barb 115 is attached to suture body 112. One or both sutureends (not shown) are pointed for penetrating tissue and it iscontemplated that one or both may comprise a surgical needle (not shown)for insertion into tissue.

[0184]FIGS. 10C and 10D are cross-sectional views respectively alongline 10C 10C and line 10D 10D of FIG. 10B. FIG. 10C and 10D furtherclarify that barb 115 becomes narrower going from base 119 toward tip117.

[0185] Suture 110 may be made with the same cutting machine as theabove-discussed sutures, such as the cutting device described in theabove-noted Ser. No. 09/943,733 to Genova et al. To achieve barb 115having arcuate base 119, the cutting device is provided with cuttingblades with ends that are correspondingly arcuate with respect toarcuate base 119.

[0186] It is intended that any of the barbed sutures of the presentinvention as described here may have barbs with a configuration thatincludes an arcuate base. The arcuate base should enhance tissueanchoring as compared to a flat, linear base. Regardless, it is notdesired for the base to be circular or oval, which would result fromconical shaped barbs, as that could decrease tissue anchoring.

[0187] Shown in FIG. 11 is a sectional side view of a barbed suture thatis another embodiment of the present invention, and that is generallydesignated at 120. Suture 120 includes elongated body 122 that isgenerally circular in cross section. Elongated body 122 terminates inend 124. End 124 is pointed for penetrating tissue and it iscontemplated that end 124 may comprise a surgical needle (not shown) forinsertion into tissue. (The other end is not shown, and also may bepointed for penetrating tissue and may comprise a surgical needle forpenetrating tissue.) Also, suture 120 includes plurality of closelyspaced barbs 125, plurality of closely spaced barbs 127, and pluralityof closely spaced barbs 129. Barbs 125 are relatively small in size witha relatively short barb length as compared to barbs 127, which arerelatively medium in size with a relatively medium barb length, ascompared to barbs 129, which are relatively large in size with arelatively long barb length.

[0188] Suture 120 may be made with the same cutting machine as theabove-described sutures were made, such as the cutting device describedin the above-noted Ser. No. 09/943,733 to Genova et al. By altering theamount of blade movement during cutting into a suture filament, then thebarb cut length is made longer or shorter, as desired, to result in eachof the three sets of barbs 125, 127, and 129 being of a size differentfrom the others, where the varying sizes are designed for varioussurgical applications. The barb size may also vary in the transversedirection, whereby the barb base may be short, medium, or long, andregardless, the barb base typically is less than about 1 of the suturediameter.

[0189] For instance, relatively larger barbs are desirable for joiningfat and soft tissues, whereas relatively smaller barbs are desirable forjoining fibrous tissues. Use of a combination of large, medium, and/orsmall barbs on the same suture helps to ensure maximum anchoringproperties when barb sizes are customized for each tissue layer. Onlytwo different sized sets of barbs (not shown) may be escarped intosuture body 122, or additional sets of barbs (not shown) with four,five, six, or more different sized sets than three sizes as illustratedfor sets of barbs 125,127, and 129 may be escarped into suture body 122as desired, in accordance with the intended end use. Also, althoughsuture 120 is illustrated with the barbs being unidirectional, it isintended that barbed sutures with barbs having a configuration ofvarying sizes in accordance with the invention also may bebi-directional barbed sutures or random barbed sutures or any of theother inventive barbed sutures described here.

[0190]FIG. 12A is a perspective view of another embodiment of thepresent invention, showing barbed suture 130 having elongated body 132of generally circular cross section. One or both suture ends (not shown)are pointed for penetrating tissue and it is contemplated that one orboth ends may comprise a surgical needle (not shown) for insertion intotissue.

[0191] Suture 130 further includes plurality of barbs 135 projectingfrom body 132 such that at least two longitudinally adjacent first andsecond barbs 135 are disposed on body 132 where first barb 135 overlapssecond barb 135 if first and second barbs 135, which is readily apparentif barbs 135 are laid flat on body 132.

[0192]FIG. 12B is a perspective view of a portion of overlapping barbs135 of the overlapping disposition barbed suture 130 of FIG. 12A, andFIG. 12C is a top plan view of FIG. 12B. FIG. 12D is a cross-sectionalview along ling 12D 12D of FIG. 12C. As can be more clearly seen fromFIGS. 12B, 12C, and 12D, during escarpment of barbs 135, overlappingfirst barb 135 is escarped into part of topside TS of overlapped secondbarb 135, and so on. Part of topside TS of overlapped second barb 135becomes part of underside US of overlapping first barb 135.

[0193] Thus, with the overlapping disposition, the barb cut distancebetween first barb 135 and second barb 135 may be shorter than the barbcut length of overlapped second barb 135, whereas, in general for barbedsutures, the barb cut distance between two barbs>the barb cut length.Particularly for the overlapping barb disposition, very suitable barbedsutures may have a ratio of the barb cut distance to the barbed suturediameter from about 1.5 down to about 0.2, since the barb cut distance Pmay be as low as about 0.1. (See discussion of FIG. 7 for commentsvis-á-vis the barb cut length and the barb cut distance.) Thisoverlapping disposition allows for closely packing many barbs 135 onbody 132, and typically, barbs 135 are thin, as compared to when thebarb cut distance between two barbs>the barb cut length.

[0194] Also, although suture 130 is illustrated with barbs 135 beingunidirectional, it is intended to include that suture 130 in accordancewith the invention also may be a bi-directional barbed suture asdescribed here.

[0195]FIGS. 13A, 13B, 13C, and 13D show various surgical needles, wherea barbed suture is attached to each surgical needle. In order tofacilitate insertion into tissue, the surgical needles may be coatedwith a polymer, for instance, as described above vis-á-vis U.S. Pat. No.5,258,013 to Granger et al.

[0196]FIG. 13A shows surgical needle N1 that is a straight elongatedneedle in the longitudinal direction and that is generally circular incross section. Surgical needle N1 has pointed tip T1 for insertion intotissue and also has hole H1. Surgical needle N1 is illustrated asattached, such as by swaging, to barbed suture S1. Barbed suture S1 is abarbed suture including, but not limited to, any of the above-describedbarbed sutures. Additionally, surgical needle N1 has diameter D1 in thetransverse direction, which is illustrated as a relatively thindiameter, such as about 0.02 inch (about 0.51 mm). As discussed abovevis-a-vis swaging, surgical needle N1, after having suture S1 insertedinto hole H1, may be crimped by standard procedures about hole H1 tohold suture S1 in place for suturing tissue.

[0197]FIG. 13B shows surgical needle N2 that is a straight elongatedneedle in the longitudinal direction and that is generally circular incross section. Surgical needle N2 has pointed tip T2 for insertion intotissue and also has hole H2. Surgical needle N2 is illustrated asattached, such as by swaging, to barbed suture S2. Barbed suture S2 is abarbed suture including, but not limited to, any of the above-describedbarbed sutures. Additionally, surgical needle N2 has diameter D2 in thetransverse direction, which is illustrated as a suitably thin diameter,such as about 0.032 inch (about 0.81 mm), but not as thin as diameter D1of surgical needle N1. As discussed above vis-á-vis swaging, surgicalneedle N2, after having suture S2 inserted into hole H2, may be crimpedby standard procedures about hole H2 to hold suture S2 in place for usein suturing tissue.

[0198]FIG. 13C shows surgical needle N3 that is a curved elongatedneedle in the longitudinal direction and that is generally circular incross section. Surgical needle N3 has pointed tip T3 for insertion intotissue and also has hole H3. Surgical needle N3 is illustrated asattached, such as by swaging, to barbed suture S3. Barbed suture 53 is abarbed suture including, but not limited to, any of the above-describedbarbed sutures. Additionally, surgical needle N3 has diameter D3 in thetransverse direction, which is illustrated as a relatively thindiameter, such as about 0.02 inch (about 0.51 mm). As discussed abovevis-á-vis swaging, surgical needle N3, after having suture S3 insertedinto hole H3, may be crimped by standard procedures about hole H3 tohold suture S3 in place for use in suturing tissue.

[0199]FIG. 13D shows surgical needle N4 that is a curved elongatedneedle in the longitudinal direction and that is generally circular incross section. Surgical needle N4 has pointed tip T4 for insertion intotissue and also has hole H4. Surgical needle N4 is illustrated asattached, such as by swaging, to barbed suture S4. Barbed suture S4 is abarbed suture including, but not limited to, any of the above-describedbarbed sutures. Additionally, surgical needle N4 has diameter D4 in thetransverse direction, which is illustrated as a suitably thin diameter,such as about 0.032 inch (about 0.81 mm), but not as thin as diameter D3of surgical needle N3. As discussed above vis-á-vis swaging, surgicalneedle N4, after having suture S4 inserted into hole H4, may be crimpedby standard procedures about hole H4 to hold suture S4 in place for usein suturing tissue.

[0200] Needle tips T1, T2, T3, and T4 are schematically illustrated aspointed, but, as is well known, surgical needles come with various kindsof pointed tips, such as taper point, taper cutting, ball point, cuttingedge, diamond point, thin line, and lancet point, and it is intended toinclude, but not be limited to, all such needle tips. Taper point, tapercutting, and diamond point are preferred needle tips for surgicalneedles used with barbed sutures.

[0201] As is well known in the art, needle diameter for surgical needlesused with conventional (i.e., unbarbed) sutures is consideredunimportant, and often very thick surgical needles are used with thinconventional sutures such that the ratio of surgical needle diameter toconventional suture diameter is 4:1 or even higher, such as 4.43:1.

[0202] However, with the surgical needle/barbed suture combination ofthe present invention (for either a straight needle or a curved needle),the thinner that the surgical needle is, then the more preferable thatthe surgical needle/barbed suture is, with the desired needle diameterbeing thinner and thinner as it approaches the barbed suture diameter,and it is possible that the needle diameter may be even thinner than thebarbed suture diameter.

[0203] In general for the present invention, a relatively thin surgicalneedle attached to a barbed suture is more preferable for approximatingtissue when stitching a wound closed than a relatively thick surgicalneedle threaded with a barbed suture. The reason is that the relativelythin surgical needle attached to a barbed suture allows for greaterengagement of barbs in tissue, and therefore provides better closurestrength to the approximated tissue that has been sutured to prevent theopposing sides of the closed wound from pulling apart, as compared tothe closure strength provided to approximated tissue that has beensutured with the relatively thick surgical needle.

[0204] The most important feature for the combination of the surgicalneedle attached to the barbed suture is that the surgical needlediameter should be of sufficient width in order to make a hole or achannel in the end, such by drilling, to allow for insertion of thebarbed suture into the hole or the channel. Nevertheless, as thesurgical needle diameter increases, the surgical needle is stillsuitable as long as the ratio of the surgical needle diameter to thebarbed suture diameter is about 3:1 or less.

[0205] Accordingly, a desirable ratio of surgical needle diameter tobarbed suture diameter, for either a straight needle or a curved needle,is about 3:1 or less, more preferably about 2:1 or less, most preferablyabout 1.8:1 or less. Furthermore, particularly if channel needles areemployed, the ratio of surgical needle diameter to barbed suturediameter may be as low as about 1:1 or less, or even lower, forinstance, about 0.9:1 or less, or about 08:1 or less, or as low as about0.5:1. It will be appreciated by the person of ordinary skill in the artthat care should be taken with extremely thin needles so as toameliorate the possibility of localized weakness, which may compromisetissue insertion.

[0206] Closure strength of thin surgical needles, both having a ratio ofsurgical needle diameter to barbed suture diameter suitable for thepresent invention, was tested as follows.

[0207] Various pieces of chamois leather (manufactured by U.S. Chamoisof Florida) having a thickness of about 0.6 in (about 15.2 mm) were cutwith a wound having a length of about 1.25 inch (about 32 mm).

[0208] A first specimen was made from a piece of chamois leather bystitching together the respective edges of the wound with a drilled endsurgical needle (item no. 382077A purchased from Sulzle Company) whichwas swaged with a barbed suture. In other words, after insertion of thebarbed suture into the needle hole, the needle was crimped about thehole to secure the barbed suture during stitching. After stitchingclosed the wound, the piece of chamois leather was cut to a rectangularshape of about 3 inches (about 76 mm) in length by about 1.25 inches(about 32 mm) in width, where the stitched wound was in the middle ofthe length and transverse the width. The needle was a taper point,curved surgical needle (⅜ of a circle), with a length of about 22 mm anda relatively thin diameter of about 0.020 inch (about 0.51 mm).

[0209] Then, using the same stitching method, a second specimen was madefrom another piece of chamois leather by stitching together therespective edges of the wound, using a drilled end surgical needle (itemno. 383271A purchased from Sulzle Company) swaged with the same kind ofbarbed suture, i.e., the surgical needle was crimped about the needlehole, after insertion of the barbed suture into the hole, to secure thebarbed suture during stitching. For the second specimen, the needle wasa taper point curved surgical needle (⅜ of a circle) with a length ofabout 22 mm and a suitable thin diameter of about 0.032 inch (about 0.81mm), although not as thin as the diameter of the needle used for firstspecimen.

[0210] Each barbed suture for each specimen was a bi-directional, twistcut multiple spiral, polydioxanone barbed suture like suture 70 in FIG.6A, except that each barbed suture had a diameter of about 0.0115 inch(about 0.291 mm, which is slightly larger than the USP requirement for asize 3-0 synthetic absorbable suture), instead of a suture diameter ofabout 0.018 inch (about 0.457 mm).

[0211] Both the first and the second specimens of stitched chamois clothwere tested for closure strength using a Test Resources UniversalTester, Model 200Q. Each specimen was gripped by two respective serratedjaws. Then, each specimen was pulled longitudinally at a rate of about10 inches per minute (about 254 mm per minute) until complete rupture.The peak load in pounds reached before complete wound disruption wasrecorded as the closure strength. The results were that the firstspecimen (which was sutured with the needle that had a relatively thindiameter of about 0.020 inch, about 0.51 mm) took 5.88 pounds untilwound disruption occurred and the specimen pulled apart back into 2pieces, whereas the second specimen (which was stitched with the needlethat had a suitably thin diameter of about 0.032 inch, about 0.81 mm,but not as thin as the needle for the first specimen) took only 2.88pounds until the wound disruption and the specimen pulled apart backinto 2 pieces.

[0212] The results are summarized in Table 13A below. TABLE 13A (ChamoisCloth Closure Strength) Needle Barbed Suture Pounds to Specimen DiameterDiameter Ratio* Rupture First 0.020 inch 0.0115 inch 1.74 5.88 Second0.032 inch 0.0115 inch 2.78 2.88

[0213] Also, various pieces of rat skin were cut and stitched fortesting of more surgical needles swaged with barbed sutures as follows.

[0214] Three freshly killed Sprague-Dawley rats, each about 600 to 700g, were used. Two full-thickness skin incisions were made on the back ofeach rat to create wounds. Each wound was about 4 cm in length andparallel to the spine.

[0215] For each rat, one of the two wounds was closed with a drilledend, curved surgical needle that was a Sulzle item no. 382273A, whichwas ⅜ circle. The needle had a length of 18 mm and a diameter of about0.022 inch (about 0.56 mm). Also, the needle had a taper point needletip where the needle tip had been ground to a 3-facet cut to approximatea taper cutting needle tip to facilitate penetration of rat tissue. Theneedle was swaged to a barbed suture.

[0216] The other of the two wounds was closed using the same suturingtechnique, but with a drilled end, curved surgical needle that was aSulzle item no. 832679A, which was ⅜ circle. The needle had a length ofabout 18 mm and a diameter of about 0.026 inch (about 0.66 mm). Also,the needle had a diamond point needle tip. The needle was swaged to abarbed suture.

[0217] Each barbed suture for each specimen was a bi-directional, twistcut multiple spiral, polydioxanone barbed suture like suture 70 in FIG.6A, except that each barbed suture had a diameter of about 0.015 inch(about 0.381 mm, which is slightly larger than the USP requirement for asize 2-0 synthetic absorbable suture), instead of a suture diameter ofabout 0.018 inch (about 0.457 mm).

[0218] For each stitched wound, a tissue specimen that was approximatelya square measuring about 4 cm×about 4 cm, with the stitched wound in themiddle paralleling two opposing tissue edges, was retrieved for closurestrength testing.

[0219] The force to open each wound was determined using a TestResources Universal Tester, Model 200Q. For each tissue specimen, thetwo edges paralleling each stitched wound were mounted in the tworespective serrated jaws of the tester.

[0220] Then, each specimen was pulled longitudinally at a rate of about2 inches per minute (about 51 mm per minute) until complete ruptureoccurred. The maximum force encountered before complete wound disruptionwas recorded as the closure strength.

[0221] The results were averaged from the first set of three woundsclosed with a needle having a diameter of about 0.022 inch (about 0.56mm) and swaged to a barbed suture. Also, the results were averaged fromthe second set of three wounds closed with a needle having a diameter ofabout 0.026 inch (about 0.66 mm) and swaged to a barbed suture.

[0222] The results are summarized in Table 13B below. TABLE 13B (RatSkin Closure Strength) Average Needle Barbed Suture of 3 WoundsSpecimens Diameter Diameter Ratio* Pounds to Rupture First Set of 30.022 inch 0.015 inch 1.47 11.9 Second Set 0.026 inch 0.015 inch 1.738.1 of 3

[0223] Thus, the lower the ratio of surgical needle diameter to barbedsuture diameter, then the better the closure strength when suturing awound closed with a surgical needle attached to a barbed suture. Ingeneral, the thinner the surgical needle, the better the closurestrength, particularly for delicate tissues; however, for tough tissues,such as muscle and bowel, thicker needles are preferred. Thus, what isimportant, regardless of whether the needle is thick or thin orsomewhere in the middle, is that the ratio of surgical needle diameterto barbed suture diameter should be about 3:1 or less, more preferablyabout 2:1 or less.

[0224] Although the present invention has been shown and described indetail with regard to only a few exemplary embodiments of the invention,it should be understood by those skilled in the art that it is notintended to limit the invention to the specific embodiments disclosed.Various modifications, omissions, and additions may be made to thedisclosed embodiments without materially departing from the novelteachings and advantages of the invention, particularly in light of theforegoing teachings. For instance, the barbed suture of the presentinvention can be used alone or with other closure methods, such asstaples and/or skin adhesives, to aid in holding the position of thetissue. Accordingly, it is intended to cover all such modifications,omissions, additions, and equivalents as may be included within thespirit and scope of the invention as defined by the following claims.

1. A barbed suture for connecting human or animal tissue in combinationwith a surgical needle, said combination comprising a barbed sutureattached to a surgical needle, wherein the suture comprises a pluralityof barbs projecting from an elongated body having a first end and asecond end and a diameter, each barb facing in a direction and beingadapted for resisting movement of the suture, when in tissue, in anopposite direction from the direction in which the barb faces, andwherein the surgical needle has a diameter with a ratio of the surgicalneedle diameter to the barbed suture diameter of about 3:1 or less 2.The barbed suture and surgical needle combination according to claim 1,wherein the barbed suture and the surgical needle have an attachmentselected from the group consisting of swaging, channel wrapping, heatshrinking, and eyelet threading.
 3. The barbed suture and surgicalneedle combination according to claim 1, wherein the surgical needle hasa polymeric coating.
 4. The barbed suture and surgical needlecombination according to claim 3, wherein the polymeric coatingcomprises a silicone material.
 5. The barbed suture and surgical needlecombination according to claim 1, wherein the ratio of the surgicalneedle diameter to the barbed suture diameter is about 2:1 or less. 6.The barbed suture and surgical needle combination according to claim 5,wherein the ratio of the surgical needle diameter to the barbed suturediameter is about 1:1 or less.
 7. The barbed suture and surgical needlecombination according to claim 6, wherein the ratio of the surgicalneedle diameter to the barbed suture diameter is about 0.9:1 or less. 8.The barbed suture and surgical needle combination according to claim 1,wherein the suture is made from a material selected from the groupconsisting of a bio-absorbable material, a non-absorbable material, andcombinations thereof.
 9. The barbed suture and surgical needlecombination according to claim 8, wherein the bio-absorbable material isselected from the group consisting of polydioxanone, polylactide,polyglycolide, polycaprolactone, and combinations thereof.
 10. Thebarbed suture and surgical needle combination according to claim 8,wherein the non-absorbable material is selected from the groupconsisting of a polymer, a metal, a metal alloy, a natural fiber, andcombinations thereof.
 11. The barbed suture and surgical needlecombination according to claim 10, wherein the polymer is selected fromthe group consisting of polyamide, polyester, polypropylene,polyurethane, polytetrafluoroethylene, polyether-ester, and combinationsthereof.
 12. The barbed suture and surgical needle combination accordingto claim 1, wherein the barbs have a disposition on the body selectedfrom the group consisting of a staggered disposition, a twist cutmultiple spiral disposition, an overlapping disposition, a randomdisposition, and combinations thereof.
 13. The barbed suture andsurgical needle combination according to claim 12, wherein the barbs arein a staggered disposition, a twist cut multiple spiral disposition, anoverlapping disposition, or a combination thereof, and the barbs are allfacing in a direction toward only one of the first end and the secondend.
 14. The barbed suture and surgical needle combination according toclaim 12, wherein the barbs are in a staggered disposition, a twist cutmultiple spiral disposition, an overlapping disposition, or acombination thereof, and the barbed suture has at least a first barbedportion and a second barbed portion, wherein the barbs of the firstportion are facing in a direction toward only the first end and thebarbs of the second portion are facing in a direction toward only thesecond end.
 15. The barbed suture and surgical needle combinationaccording to claim 12, wherein the staggered disposition includes afirst set of the barbs being radially spaced about 180 degrees from asecond set of the barbs.
 16. The barbed suture and surgical needlecombination according to claim 12, wherein the staggered dispositionincludes a first set of the barbs being radially spaced about 120degrees from a second set of the barbs and the second set of the barbsbeing radially spaced about 120 degrees from a third set of the barbs.17. The barbed suture and surgical needle combination according to claim12, wherein the barbs are in a twist cut multiple spiral disposition andthe barbed suture is made from a suture filament having a portion thatis twisted from about 2 to about 17 times per inch when the barbs areescarped into the suture filament to make the barbed suture.
 18. Thebarbed suture and surgical needle combination according to claim 12,wherein the barbs are in a twist cut multiple spiral disposition and thesuture has a spirality angle α ranging from about 5 degrees to about 25degrees.
 19. The barbed suture and surgical needle combination accordingto claim 18, wherein the spirality angle α ranges from about 7 degreesto about 22 degrees.
 20. The barbed suture and surgical needlecombination according to claim 19, wherein the spirality angle of rangesfrom about 10 degrees to about 18 degrees.
 21. The barbed suture andsurgical needle combination according to claim 12, wherein the barbs arein an overlapping disposition such that for at least two adjacent barbs,one being an overlapping barb and one being an overlapped barb, theoverlapping barb has an underside and the overlapped barb has a topsidewhere part of the underside of the overlapping barb is derived from partof the topside of the overlapped barb.
 22. The barbed suture andsurgical needle combination according to claim 21, wherein each of theoverlapping barb and the overlapped barb has a barb cut length, and theoverlapping barb and the overlapped barb have a barb cut distancebetween them that is less than the barb cut length of the overlappedbarb.
 23. The barbed suture and surgical needle combination according toclaim 1, wherein the barbs have a configuration selected from the groupconsisting of (i) a barb cut angle Θ ranging from about 140 degrees toabout 175 degrees, (ii) a barb cut depth with a ratio of the barb cutdepth to the suture diameter ranging from about 0.05 to about 0.6, (iii)a barb cut length with a ratio of the barb cut length to the suturediameter ranging from about 0.2 to about 2, (iv) a barb cut distancewith a ratio of the barb cut distance to the suture diameter rangingfrom about 0.1 to about 6, (v) a corrugated barb underside, (vi) anarcuate barb base, (vii) at least two sets of barbs with each set havinga barb size different from the barb size of the other set, and (viii)combinations thereof.
 24. The barbed suture and surgical needlecombination according to claim 23, wherein the barb cut angle Θ rangesfrom about 145 degrees to about 173 degrees.
 25. The barbed suture andsurgical needle combination according to claim 24, wherein the barb cutangle Θ ranges from about 150 degrees to about 170 degrees.
 26. Thebarbed suture and surgical needle combination according to claim 23,wherein the ratio of the barb cut depth to the suture diameter rangesfrom about 0.1 to about 0.55.
 27. The barbed suture and surgical needlecombination according to claim 26, wherein the ratio of the barb cutdepth to the suture diameter ranges from about 0.2 to about 0.5.
 28. Thebarbed suture and surgical needle combination according to claim 23,wherein the ratio of the barb cut length to the suture diameter rangesfrom about 0.4 to about 1.7.
 29. The barbed suture and surgical needlecombination according to claim 28, wherein the ratio of the barb cutlength to the suture diameter ranges from about 0.8 to about 1.5. 30.The barbed suture and surgical needle combination according to claim 23,wherein the ratio of the barb cut distance to the suture diameter rangesfrom about 0.5 to about 4.5.
 31. The barbed suture and surgical needlecombination according to claim 30, wherein the ratio of the barb cutdistance to the suture diameter ranges from about 1 to about 3.5.
 32. Abarbed suture for connecting human or animal tissue in combination witha surgical needle, said combination comprising a barbed suture attachedto a surgical needle, wherein the suture comprises a plurality of barbsprojecting from an elongated body having a first end, a second end, anda diameter, each barb facing in a direction and being adapted forresisting movement of the suture, when in tissue, in an oppositedirection from the direction in which the barb faces, wherein the barbedsuture and the surgical needle have an attachment selected from thegroup consisting of swaging, channel wrapping, heat shrinking, andeyelet threading, and wherein the surgical needle has a diameter with aratio of the surgical needle diameter to the barbed suture diameter ofabout 3:1 or less.
 33. A barbed suture for connecting human or animaltissue in combination with a surgical needle, said combinationcomprising a barbed suture attached to a surgical needle, wherein thesuture comprises a plurality of barbs projecting from an elongated bodyhaving a first end, a second end, and a diameter, each barb facing in adirection and being adapted for resisting movement of the suture, whenin tissue, in an opposite direction from the direction in which the barbfaces, wherein the barbs are in a staggered disposition, and wherein thesurgical needle has a diameter with a ratio of the surgical needlediameter to the barbed suture diameter of about 3:1 or less.
 34. Abarbed suture for connecting human or animal tissue in combination witha surgical needle, said combination comprising a barbed suture attachedto a surgical needle, wherein the suture comprises a plurality of barbsprojecting from an elongated body having a first end, a second end, anda diameter, each barb facing in a direction and being adapted forresisting movement of the suture, when in tissue, in an oppositedirection from the direction in which the barb faces, wherein the barbsare in a twist cut multiple spiral disposition and the suture has aspirality angle α ranging from about 5 degrees to about 25 degrees, andwherein the surgical needle has a diameter with a ratio of the surgicalneedle diameter to the barbed suture diameter of about 3:1 or less. 35.A barbed suture for connecting human or animal tissue in combinationwith a surgical needle, said combination comprising a barbed sutureattached to a surgical needle, wherein the suture comprises a pluralityof barbs projecting from an elongated body having a first end, a secondend, and a diameter, each barb facing in a direction and being adaptedfor resisting movement of the suture, when in tissue, in an oppositedirection from the direction in which the barb faces, wherein the barbsare in an overlapping disposition such that for at least two adjacentbarbs, one being an overlapping barb and one being an overlapped barb,the overlapping barb has an underside and the overlapped barb has atopside where part of the underside of the overlapping barb is, derivedfrom part of the topside of the overlapped barb, and wherein thesurgical needle has a diameter with a ratio of the surgical needlediameter to the barbed suture diameter of about 3:1 or less.
 36. Abarbed suture for connecting human or animal tissue in combination witha surgical needle, said combination comprising a barbed suture attachedto a surgical needle, wherein the suture comprises a plurality of barbsprojecting from an elongated body having a first end, a second end, anda diameter, each barb facing in a direction and being adapted forresisting movement of the suture, when in tissue, in an oppositedirection from the direction in which the barb faces, wherein the barbsare in a staggered disposition, and wherein the surgical needle has adiameter with a ratio of the surgical needle diameter to the barbedsuture diameter of about 3:1 or less.